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Oxaliplatin, Leucovorin, and Fluorouracil Before and After Radiation Therapy and Surgery in Treating Patients With Rectal Cancer That Can Be Removed by Surgery

NCT01263171 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-09-21

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying giving oxaliplatin, leucovorin, and fluorouracil together, before and after radiation therapy and surgery in treating patients with rectal cancer that can be removed by surgery.

Conditions

Interventions

DRUG

Leucovorin

DRUG

fluorouracil

DRUG

leucovorin calcium

DRUG

oxaliplatin

PROCEDURE

adjuvant therapy

PROCEDURE

neoadjuvant therapy

PROCEDURE

therapeutic conventional surgery

RADIATION

radiation therapy

Sponsors & Collaborators

Principal Investigators

  • Simon Gollins, MD · Glan Clwyd Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01263171 on ClinicalTrials.gov